Although we don't believe in timing the market or panicking over market movements, we do like to keep an eye on big changes -- just in case they're material to our investing thesis.
What: Shares of NewLink Genetics (NASDAQ: NLNK ) , a clinical-stage biopharmaceutical company developing immunotherapeutic options to treat cancer, fell as much as 15% after providing an update on its IMPRESS phase 3 pancreatic cancer trial involving algenpantucel-L.
So what: According to NewLink Genetics' press release, the independent data safety monitoring committee recommended that its IMPRESS study continue without modification after completing its first or two planned interim data analysis. This first analysis was planned once there were 222 patient events, followed by a second analysis at 333 patient events, and perhaps a final analysis at 444 patient events. In the words of Chairman and CEO Dr. Charles Link, "As we have previously emphasized, continuation of this study was an anticipated outcome considering the high statistical threshold assigned to this first interim analysis under the special protocol assessment."
Now what: While there's nothing inherently bad in today's IMPRESS trial update, there's also no upside catalyst that some investors had clearly been looking for. Given the promise surrounding NewLink's HyperAcute immunotherapy platform -- which works by encouraging modified cancer cell lines to express alpha-gal, a carbohyrdrate that we have a natural immunity to and that could attract an immune response -- there had been hope that the DSMC would stop the trial early due to a very high bar of statistical efficacy. Since that failed to happen, some of those same shareholders are now clearly wondering how much of a benefit algenpantucel-L may pack. Based on the data I've seen from its phase 2 studies, I'm still very intrigued by its potential. There hasn't been a revolutionary new approach to pancreatic cancer treatment in quite some time, and NewLink's experimental therapy could be that answer. I would certainly encourage you to add NewLink Genetics to your watchlist.
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